A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD)
NCT ID: NCT00626535
Last Updated: 2009-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2003-03-31
2004-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Esomeprazole in Patients With Frequent Heartburn
NCT01370525
Efficacy of Esomeprazole in Patients With Frequent Heartburn
NCT01370538
Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
NCT00241540
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)
NCT00628342
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
NCT00206284
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
20mg once daily
Esomeprazole
20mg Oral Once Daily
2
Oral once daily
Matching placebo
Oral Once Daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Esomeprazole
20mg Oral Once Daily
Matching placebo
Oral Once Daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Episodes of heartburn 2 or more days during the 7 days prior to the screening visit. Moderate or severe upper abdominal pain on at least 3 out of the 7 consecutive days of the run-in period.
* A normal endoscopy within 14 days of Visit 1 of between Run-in and randomization.
Exclusion Criteria
* History of esophageal, gastric or duodenal surgery, except for closure of an ulcer.
* History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
* Further diseases / conditions, as listed in the protocol.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
AstraZeneca
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paula Fernstrom
Role: STUDY_DIRECTOR
Nexium Global Product Director, AstraZeneca
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D9619C00001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.